The Director QA acts as the Designated Representative ensuring compliance with NABP VAWD requirements and all relevant regulations for Gilead products in the US market
Job Summary
The Director QA acts as the Designated Representative ensuring compliance with NABP VAWD requirements and all relevant regulations for Gilead products in the US market.
This role requires deep knowledge of GDP, PDMA, and DSCSA to support operational processes and lead market actions including recalls and investigations.
Gilead offers a competitive salary range of $210,375.00 to $272,250.00 along with discretionary bonuses, stock incentives, and comprehensive benefits packages.
Matching Summary
The Director QA acts as the Designated Representative ensuring compliance with NABP VAWD requirements and all relevant regulations for Gilead products in the US market.
Salary
Base: $210,375.00 - $272,250.00; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives eligible; Benefits: Medical, dental, vision, life insurance, and paid time off included
Skills & Requirements
Must-have
Good Distribution Practices GDP compliance
Drug Supply Chain Security Act DSCSA knowledge
Prescription Drug Marketing Act PDMA expertise
FDA inspection hosting experience
Designated Representative DR responsibilities
California Board of Pharmacy licensing management
Nice-to-have
Strong stakeholder engagement skills
Strategic process improvement leadership
Cross-functional collaboration abilities
Risk assessment and gap analysis skills
Inclusive team development mindset
Key Requirements
BS/BA degree with 12+ years or MS/MA with 10+ years pharmaceutical experience
Pharmacy degree or equivalent required
Proven experience supporting and hosting FDA inspections
Deep proficiency in US market distribution regulations